Institutional Evaluation Committee (CIE)

Next dates: 

• 8 and January 29
• 12 and 26 February
• 12 and 26 March
• 9 y 23 de abril
• And May 7 21
• 4 18 and June
• 2 & 16 of July
• 6 y 20 August
• 3 and September 17
• 1, 15 and 29 October
• November 12th
• December 3 and 17

NotaThe documentation must be sent one week before each meeting.

• Any high-risk research study (such as a clinical trial, a new surgical procedure, or a new medical device).
• Studies of zero or minimal risk according to Art 6, Law 15462.

Consult in FAQ step by step, to carry out your research.

The CIE participates exclusively in studies conducted in la jurisdiction of Health Region V of the province of Buenos Aires. 

What is the process for research approval?  

• If you need statistical advice, consult the DDA (Department of Academic Development). 
• If it is an industry-sponsored study, consult the CUI (Clinical Research Unit).  
• If the study is ready, submit all documents to the CIE (Institutional Evaluation Committee), which is who decides its approval.  

What do I need to be able to do a research study? 

• If you want to do research with patient health data, check out “Research using data from medical records and other sources of health information” 

• See the MOCIE Annexes to see templates for the Protocols and Informed Consents needed to create your project. 

Useful information:  

DDA: dda@austral.edu.ar

Director: Dr. Alejandro Hita 

      Hours: Monday to Friday from 9 a.m. to 13 p.m.    

      Location: HUA Address  

      Phone: 0230-4482428 

CIE: cie@austral.edu.ar

President: Ana de Pablo, Specialist 

     Opening hoursMonday to Friday from 9 a.m. to 14 p.m.  

      Location: FCB, 4th floor – Dean's Office  

      Phone: 0230-4387407 

UIC: uic@austral.edu.ar

DDirector: Marcelo Silva, Specialist  

      Hours: Monday to Friday from 9 a.m. to 13 p.m. 

      Location: HUA Mezzanine  

      Telephone: 0230-4387649 – 4387405   

How long does it take for a project to be evaluated by the CIE? 

The application is submitted when it is complete. If you submit all the required documentation, you will receive a decision within 15 to 21 days. This decision may be approval, rejection, or a request for changes. You will be notified by the CIE as soon as it is ready. 

If changes are requested, the response must be submitted within 30 days.  

How do I know what requirements my research must meet? 

Ask the MOCIE and Annexes to the MOCIE On this website, you will find useful information and documentation that you can consult and use (such as protocol and informed consent templates). Consider what type of study you plan to conduct—observational or interventional—or whether you want to create a survey or a registry, and select the most appropriate template accordingly. 

Do all studies require ICD approval and informed consent? 

They do not require ICD approval. esobservational studies that meet either of these two premises:  

• Do not perform on human beings 
• Use publicly available data (for example, a population census)  

They require prior approval from the ICD  

• Any intervention study (drugs or medical technology) 

• Observational studies involving procedures in addition to usual practice (e.g., an extra hospital visit, a questionnaire or survey, an extra blood draw)  

• Observational studies with health data and/or biological samples  

What do I need to do before presenting a paper at a conference or getting it published? 

The CAS must know what, when and where a job is presented with the affiliation Hospital Universitario Austral/Universidad Austral. 

Send the presentation details (title, authors, place and date of presentation) or publication to the DDA.

The research study on which the work to be presented or published is based must have prior authorization. 

The CIE may issue an opinion authorizing the articles when they correspond to a Case Report or Case Series. 

PROCESSES FOR ORAL PRESENTATIONS AND SCIENTIFIC PUBLICATIONS 

Articles that you wish to publish or presentations that you plan to make at conferences or other scientific meetings, with the affiliation of Universidad Austral/Hospital Universitario Austral, must be submitted to the Academic Development Department (DDA). 

Protocols those on which said articles or presentations are based must have the ICD prior approval where applicable. (See FAQ: “Do all studies require ICN approval and informed consent?”)  

The CIE may issue an opinion authorizing the articles when they correspond to a Case Report or Case Series.  

• MOCIE – 2025
• Annex MOCIE – 2025

Database:

• Database entry form
• Request for the creation of a database

The documentation to be submitted varies depending on the risk level of each study:

STUDIES OF ZERO OR MINIMAL RISK: In this case, they must complete and submit the following documents.

• Observational intake form
• Sworn declaration
• Delegation of functions obs

In addition, they must submit the following documentation:

• Dance
• Consents according to population or request for exemption.
• Database creation request (if applicable).
• Agreement / contracts (if applicable).
• Promotional material.
• Supporting materials (CRF, questionnaires, surveys)
• CV, degree and specialist title, PBA registration, current ethical certificate and GPC certificate of the principal investigator (Residents: Please clarify your status in the presentation to the CIE. Disp N° 128/2017)
• CV and GMP certificate of the delegated researchers
• Authorization of the service or department (HUA / FCB) or maximum institutional authorization (other centers)
• Center Enabling

STUDIES OF HIGHER THAN MINIMUM RISKIn this case, they must complete and submit the following documents.

• Application form for intervention studies
• Sworn declaration
• Delegation of functions v2023

In addition, they must submit the following documentation:

• Dance
• Consents according to population
• Dissemination material
• Supporting materials (CRF, questionnaires, surveys)
• Agreements – Contracts.
• Sponsor insurance and coverage certificates.
• Insurance and center coverage certificate.
• Malpractice insurance in investigation of the delegated team
• Delegation of the Researcher to the UIC (when applicable)
• Delegation or power of attorney from the Sponsor to the OIC (when applicable)
• CV, degree and specialist title (corresponding to the type of research study), PBA registration, current ethical certificate and GCP certificate of the principal investigator
• CV, current ethical certificate and GCP certificate of the delegated researchers
• Authorization of the service or department (HUA / FCB)
• Maximum institutional authorization.
• Commitment to damage coverage
• Center accreditation (other centers)

RENEWAL:

Annual renewal note template

Internal progress report

Social progress report

ENDING:

Final Health Report

Final report on social studies

NOTE: In the case of amendments to the protocol or informed consent/assent form, both a change-tracked version and a final version must be submitted.

Researchers must have their documentation up-to-date in all cases. Ethical Certificates will be valid for 30 days (Source: CCIS – CEC).

The protocol and all information for the participant must be submitted in electronic format.

1) National legislation

• Provision 4008/2017
• Provision 4009/2017
• Provision 2318/2002 TO 2004
• Provision 3802/2004
• Law 26.994 Civil and Commercial Code of the Nation
• Provision 969/97 and complementary 4457/06 for Medical Technology.
• Provision 2247/09: Guide for Clinical Studies in Type II Diabetes.
• Provision 6677/10 (Good Clinical Practice Regime for Clinical Pharmacology Studies).
• Resolution 1480/11: Guidelines for research involving human subjects.

2) Legislation of the province of Buenos Aires

• Technical Opinion 619/2017: Mandatory approval and evaluation of each project
• Technical Opinion 046/2011: Research on biological samples
• Law 15462
• Regulatory Decree 3389/24 (Law 15462)

3) Other national and international standards

• Law 25.326 on the Protection of Personal Data.
• Document E6 (R1) on Good Clinical Practices of the International Conference on Harmonization (ICH).
• U.S. Department of Health and Human Services (HHS): Code of Federal Regulations, Title 45 (Public Welfare) Part 46 (Protection of Human Subjects).
• United States Food and Drug Administration (FDA): Code of Federal Regulations, Title 21 (Food and Drugs), Part 50 (Protection of Human Subjects)y Part 56 (institutional committees)evaluation finals).

«Ethical framework on which the evaluation of the CIE is based»

• Declaration of Helsinki in its latest version.
• International Ethical Guidelines for Health-Related Research Involving Human Subjects 2016 CIOMS (Council for International Organizations of Medical Sciences))
• “Ethics of Health Care Research in Developing Countries” prepared by the Nuffield Council on Bioethics, April 2002.
• Declarations and pacts to which the Argentine Republic adheres with constitutional hierarchy and the Universal and International Declarations of UNESCO applicable to biomedical research.

These international standards provide public assurance that the rights, safety, and well-being of participants are protected and that clinical trial data are reliable.

See point 21 of MOCIE